Distental

Each film-coated tablet contains Pinaverium Bromide 50 or 100 mg which is equivalent to pinaverium 43.25 or 86.5 mg, respectively.

It also contains the following excipients: Core: Microcrystalline cellulose, pre-gelatinised starch, lactose monohydrate, anhydrous colloidal sillica, talc, magnesium stearate.

Coating: Basic butylated metacrylate copolymer, sodium lauryl sulfate, stearic acid, talc, microcrystalline cellulose, aluminium lake "sunset yellow" (E110), titanium dioxide (E171), hydroxypropyl methylcellulose.

Symptomatic treatment of pain, transit disorders & intestinal discomfort related to functional intestinal disturbances (irritable bowel syndrome, spastic colon); symptomatic treatment of pain related to functional disturbances of the biliary tract (peptic ulcer, biliary dyskinesia); preparation for a barium enema.

Adult: 50-mg: 1 tab 3 times daily. Total Daily Dose: 150 mg. The dosage may be increased up to a maximum of 2 tabs 3 times daily. Maximum Total Daily Dose: 300 mg.

100-mg: 1 tab 2 times daily. Total Daily Dose: 200 mg. The dosage may be increased up to a maximum of 1 tab 3 times daily. Maximum Total Daily Dose: 300 mg.

Pediatric Population: The experience in pediatric patient (<18 years) is limited.

Administration: Swallow the tablets without chewing or sucking them.

Take the tablets with a glass of water in the middle of a meal.

The tablet should not be swallowed when in the lying position or just before bedtime.

If you forget to take Distental tablets, it is advised not take a double dose to compensate for it.

Hypersensitivity to Distental or to any of the excipients of Distental.

Clinical trials have demonstrated the absence of any interaction between Distental and digitalis drugs (heart medications), oral antidiabetics, insulin, oral anticoagulants and heparin.

Co-administration of an anticholinergic drug may enhance spasmolysis.

No interference with laboratory tests for drug level detection was observed.

Incompatibilities: Not applicable.

Like all medicines, Distental may cause side-effects, although not everybody experiences them.

The following adverse events have been reported spontaneously during post-marketing use. A precise frequency cannot be estimated from available data (not known).

Gastrointestinal Disorders: Gastrointestinal disturbances have been observed eg, abdominal pain, diarrhea, nausea, vomiting and dysphagia (difficulty swallowing). Oesophageal lesion may occur when not applied as advised.

Skin and Subcutaneous Tissue Disorders: Cutaneous (skin) effects have been observed eg, rash, pruritus (itchiness), urticaria (hives), and erythema (reddening of the skin).

Immune System Disorders: Hypersensitivity reactions may occur.